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    Summary
    EudraCT Number:2020-004815-29
    Sponsor's Protocol Code Number:ULA03
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2021-03-10
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2020-004815-29
    A.3Full title of the trial
    Open-label, dose escalation study of ularitide for the investigation of hemodynamic effects in patients with pulmonary arterial hypertension (UPAH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 2 study to investigate the effects on the blood flow induced by step-wise increased doses of intravenously administered ularitide in patients suffering from pulmonary arterial hypertension
    A.4.1Sponsor's protocol code numberULA03
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCardiorentis AG
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCardiorentis AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCardiorentis AG
    B.5.2Functional name of contact pointCMO
    B.5.3 Address:
    B.5.3.1Street AddressChurerstrasse 77
    B.5.3.2Town/ cityPfäffikon
    B.5.3.3Post code8808
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41415526932
    B.5.6E-mailinfo@cardiorentis.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameUlaritide
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNULARITIDE
    D.3.9.1CAS number 118812-69-4
    D.3.9.2Current sponsor codeULARITIDE
    D.3.9.3Other descriptive nameUrodilatin
    D.3.9.4EV Substance CodeSUB11377MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pulmonary arterial hypertension
    E.1.1.1Medical condition in easily understood language
    Pulmonary arterial hypertension
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10064911
    E.1.2Term Pulmonary arterial hypertension
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To investigate the hemodynamic effects induced by step-wise increased doses of the IV administered natriuretic peptide ularitide in patients suffering from pulmonary arterial hypertension (PAH)
    - To investigate safety and tolerability of ularitide in patients suffering from PAH
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients 18 to 75 years of age
    2. Known diagnosis of PAH (idiopathic, hereditary, drug-associated, due to connective tissue disease, simple congenital heart defects closed >1 year) with
    a) PVR >3 WU (determined at last right heart catheterization)
    b) Mean pulmonary arterial pressure (mPAP) ≥25 mmHg (determined at last right heart catheterization)
    c) Pulmonary arterial wedge pressure (PAWP) ≤15 mmHg (determined at last right heart catheterization)
    3. Stable PAH background therapy for ≥3 months including endothelin receptor antagonists (ERAs), phosphodiesterase-5 (PDE5) inhibitors, soluble guanylate cyclase (sGC) stimulators, prostacyclin analogues, prostacyclin-receptor agonists or any combination thereof
    4. Scheduled for a control visit including right heart catherization
    5. No morning intake of PAH background medication at the day of ularitide treatment
    6. Negative pregnancy test (β-human chorionic gonadotropin) at screening in women of childbearing age
    7. Ability to understand the purpose and risks of the study and to provide signed and dated written informed consent
    E.4Principal exclusion criteria
    1. Known diagnosis of
    a) medium- or high-grade left-sided valvular disease
    b) hypertrophic obstructive cardiomyopathy
    c) chronic heart failure
    d) diastolic heart failure with preserved ejection fraction (HFpEF)
    e) state post pulmonary embolism
    f) clinically relevant parenchymal lung diseases as evidenced by
    - Ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC ratio) of <55% of predicted
    - Forced vital capacity (FVC) <60% of predicted, and
    - Diffusion capacity of the lung for carbon dioxide (DLCO) <50% of predicted.
    All respiratory values must not be older than twelve months at the time of screening and documented in the medical history of the patient. If documented values were older than 12 months from screening, patient must undergo spirometry during screening for determining these values.
    2. Contraindications for right heart catheterization such as uncontrolled coagulation disorders, uncontrolled disorders of cardiac excitation generation and conduction, permanent pacemaker, implanted defibrillator
    3. Documented left ventricular ejection fraction <40%
    4. Documented partial pressure of pulmonary arterial oxygen <50 mmHg (despite oxygen supplementation) and/or partial pressure of carbon dioxide >50 mmHg.
    5. Uncontrolled severe systemic hypertension at screening, i.e. arterial hypertension >200 mmHg (systolic) or >120 mmHg (diastolic)
    6. Estimated glomerular filtration rate (eGFR) <30 mL/kg/min at screening
    7. Severe hepatic impairment or porphyria characterized by elevations of one or both serum transaminases (alanine-aminotransferase, aspartate-aminotransferase) >3 x upper limit of normal (ULN) or bilirubin >3 x ULN at screening
    8. Use of sGC stimulators within three days prior to start of ularitide treatment
    9. Use of nitric oxide donors or sacubitril-valsartan within three days prior to start of ularitide treatment
    10. Known hypersensitivity to the active substance or to any of the excipients of the study drug or other natriuretic peptides
    11. Known Hepatitis B or C or human immunodeficiency virus infection
    12. Participation in an interventional clinical trial within one month prior to screening or 5 half-lives of the corresponding investigational medicinal product, whichever is longer
    13. Active substance abuse
    14. Legal incapacity or limited legal capacity
    15. Breastfeeding or pregnancy
    16. Employees of the sponsor or patients who are employees or relatives of the investigators
    17. Patients committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    Maximum absolute change of the PVR from baseline at the individual maximum tolerated ularitide dose.

    Safety:
    - Tolerability of ularitide (defined as number of patients with absence of stopping criteria)
    - Number of patients with premature treatment discontinuation due to safety reasons
    - Number of patients with a drop in SBP to values <90 mmHg (determined non-invasively)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary efficacy and safety endpoints will be assessed after all patients have completed their treatment.
    E.5.2Secondary end point(s)
    - Maximum relative change of the PVR from baseline at the individual maximum tolerated ularitide dose
    - Maximum absolute and relative change of PVR from baseline at each ularitide dose
    - Maximum absolute and relative change of SBP from baseline at each ularitide dose
    - Maximum absolute and relative change of diastolic blood pressure (DBP) from baseline at each ularitide dose
    - Maximum absolute and relative change of HR from baseline at each ularitide dose
    - Maximum absolute and relative change of peripheral oxygen saturation from baseline at each ularitide dose
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be assessed after all patients have completed their treatment.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-03-10. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After completion of the study subjects will not receive any further study-specific treatment. They will be provided with standard medical care treatment.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-04
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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